Established in 2020, CRCG is a collaboration between @umsop @UMichPharmacy and @US_FDA to increase access to safe and effective generic medicines.
Joined August 2021
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It's happening now! Don't miss this important workshop which would provide some helpful information on the recently published Guidances for Industry (GFIs) on topical products.
#genericdrugs #genericmedicines #topicals #drugdevelopment #regulatoryaffairs
Are you planning to join us for the Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development Workshop next week?
If you haven't already, register here: complexgenerics.org/topical-…
We look forward to seeing you next week!
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đź“Ł 2023 NanoDay Symposium: Continuous Manufacturing of Nanomaterials
Check out the upcoming event on continuous manufacturing of nanomaterials. This event will be hosted by SBIA and is free to public.
#nanomaterials #nanoparticles #drugdelivery #drugmanufacturing
7 Sep 2022
Learn about drug development of products that contain nanomaterials in their formulation & how a newly finalized guidance can be implemented at the #CDERSBIA NanoDay Symposium on Oct 11.
Eligible for RAPS, SOCRA, SQA, & ACRP CE credit.
Register ➡️ fda.gov/drugs/news-events-hu…
ALT Text graphic with FDA logo in corner. Text states CDER Small Business and Industry Assistance (SBIA) FDA NanoDay Symposium 2022 October 11 www.fda.gov/CDERSBIA
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Full Agenda and Bios are Now Available for the Oct 12 Advances in PBPK Modeling and its Regulatory Utility for Oral Drug Product Development Workshop! Join the FDA and the Center for Research on Complex Generics for our In-Person ( Virtual) event. complexgenerics.org/Oral_PBP….
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Join the FDA and the Center for Research on Complex Generics, in-person or online, for the “Mitigation Strategies for Nitrosamine Drug Substance Related Impurities: Quality and Bioequivalence Considerations for Generic Products” workshop on June 15, 2023, complexgenerics.org/NDSRIs_m…
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Join the FDA/CRCG In-Person ( Virtual) Training Course: Drug-Device Combination Products (DDCP) 101: FDA/CRCG Training on Identifying, Developing, and Evaluating DDCPs on May 10, 2023. The Full Agenda is Now Available on our website at complexgenerics.org/DDCP_101…
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Join the CRCG for its In-Person ( Virtual) Workshop at The Universities at Shady Grove; Rockville, MD on April 20-21, 2023. In-person attendees will engage in interactive group work with industry, academic, and FDA experts.
Agenda is now available at complexgenerics.org/OIDP-CCE….
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Learn from FDA and the CRCG at the “Drug-Device Combination Products 101: Identifying, Developing, and Evaluating Drug-Device Combination Products” training on May 10, 2023. For more information, follow this link: complexgenerics.org/DDCP_101…
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Join FDA and the Center for Research on Complex Generics for the “Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products” workshop on April 20-21, 2023. complexgenerics.org/OIDP-CCE…
ALT Considerations for and Alternatives to Comparative Clinical Endpoint and Pharmacodynamic Bioequivalence Studies for Generic Orally Inhaled Drug Products - April 20-21, 2023, 8:30 AM - 5:30 PM, For more information visit: https://complexgenerics.org/events/
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The Center for Research on Complex Generics (CRCG) is looking for volunteers for a Stakeholder Expert Committee (SEC) on Adhesion Testing for a Transdermal or Topical Delivery System (TDS).
For more information on how to apply, please visit complexgenerics.org/voluntee….
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Slides and videos for the December Webinar are posted on our website: complexgenerics.org
Please follow the link to the post-webinar survey available until December 22, 2022, here: umaryland.az1.qualtrics.com/…
We appreciate you and look forward to receiving your feedback!
Slides and videos for the November Workshop are posted on our website: complexgenerics.org
Please follow the link to the post-workshop survey available until December 20, 2022, here: umaryland.az1.qualtrics.com/…
We appreciate you and look forward to receiving your feedback!
Slides and videos are posted on the CRCG website: complexgenerics.org
Please follow the link to take the post-workshop survey available until November 30, 2022, here: umaryland.az1.qualtrics.com/…
We appreciate you and look forward to receiving your feedback!
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The full agenda and speaker bios for the December Workshop on Excipients and Formulation Assessments of Complex Generic Products: Best Practices and Lessons Learned are now available on the CRCG Website.
complexgenerics.org/excipien…
Are you planning to join us for the Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Generic Topical Product Development Workshop next week?
If you haven't already, register here: complexgenerics.org/topical-…
We look forward to seeing you next week!
Don’t miss the @US_FDA and @complexgenerics public workshop, Formulation Characterization and Cutaneous Pharmacokinetics to Facilitate Topical Product Development on Nov 3, 2022.
This workshop is FREE. Full Agenda is now available.
Register Now: complexgenerics.org/topical-…
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@complexgenerics is conducting a survey to identify topics for discussion with generic inhalation product developers during our in-person and virtual workshop on “Comparative Clinical Endpoint and Pharmacodynamic BE Studies for OIDPs” on April 20 – 21, 2023.
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Please provide your feedback by November 7, 2022 here: umaryland.az1.qualtrics.com/…
Your survey input is anonymous. Thank you!
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